KIT-302 is a combination drug that aims to treat osteoarthritis (OA) pain and hypertension simultaneously. KIT-302 is comprised of two FDA-approved drugs, celecoxib (the active ingredient in Pfizer’s Celebrex®) for the treatment of pain caused by OA, and amlodipine besylate (the active ingredient in Pfizer’s Norvasc®), a drug designed to treat hypertension.
In December 2015, we announced that the Phase III clinical trial for KIT-302 successfully met the primary efficacy endpoint of the trial protocol as approved by the U.S. Food & Drug Administration (FDA). The trial’s primary efficacy endpoint was to show that KIT-302 lowers daytime systolic blood pressure by at least 50% of that achieved in patients treated only with amlodipine. The trial data, in fact, revealed that KIT-302 was more efficacious at reducing blood pressure than when amlodipine was used on its own.
The trial data also showed that the favorable blood pressure effects of KIT-302 were present in all blood pressure variables measured in the study. Kitov determined that the blood pressure reduction synergy seen with combining celecoxib and amlodipine was present in daytime systolic blood pressure – the study’s primary efficacy endpoint. Based on the data, however, the blood pressure reduction synergy was also present with all other blood pressure variables and at all times of day – i.e. daytime diastolic blood pressure, nighttime systolic blood pressure, and nighttime diastolic blood pressure. Although celecoxib, when combined with amlodipine, appears to have a synergistic effect by lowering blood pressure, it lacks this effect when administered by itself.
These results not only confirm the study’s top-line findings, but also reveal that using a combination drug for treating pain can improve patient health.
Additional data from the Phase III clinical trial of KIT-302 also suggest beneficial effects on renal (kidney) function as compared to negative effects on renal function caused by other NSAIDS. The data also suggest that KIT-302 may protect against the amlodipine side effect of causing fluid retention by the kidneys.
Therefore, we have conducted a clinical trial designed to validate and better quantify these potential beneficial renal effects. The trial results may also provide an explanation for the synergistic antihypertensive effect, where the reduction in blood pressure demonstrated with KIT-302 was higher than that observed with amlodipine alone. Top-line results of this trial are expected in Q4 2017.
Kitov submitted a New Drug Application (NDA) in July 2017. The U.S. Food & Drug Administration (FDA) filed the NDA in September 2017, thereby accepting it for a full review. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of May 31, 2018, to complete its review.
Celebrex® is a registered trademark of G.D. Searle LLC (a subsidiary of Pfizer Inc.). Norvasc® is a registered trademark of Pfizer Inc.